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Posts in the ‘DePuy Hip Recall’ category

Metal on Metal (MoM) Hip Replacements: Risks, Replacements and Revisions

Posted on February 20th, 2012 by Robert D. Rowland

For years, the material of choice for total hip arthroplasty was polyethylene-lined acetabular cups, mated with ceramic or metal femoral heads. But over time, the polyethylene liner would wear out – even more quickly for more active people – requiring replacement surgery. Ceramic hip components, also a popular choice for years, could chip or break from use.

These materials led the way for the metal-on-metal (MoM) hips. Recent high-tech developments in hard metal alloys made hip components with smooth components, so a cup and head could fit together perfectly.

The new MoM hip was well-praised in the medical community, and marketed heavily as an ideal option for younger, more active patients. It was promoted as having a longer life than other hip options – 20 years or more. Yet significant problems arose, including:

Aseptic loosening: The cup becomes loose for reasons other than infection, requiring revision surgery.

Bone loss: The release of metal ions is suspected to cause osteolysis and inhibit or reverse the bony ingrowth process that holds the devices in place. Many MoM recipients first report great results, then later need revision surgery.

Metallosis: This serious reaction to the accumulation of metal ions or metal debris in the body, metallosis can result in tissue death, pseudotumors and bone degradation.

Neurological problems: Long-term exposure to cobalt and chromium ions can lead to headaches, memory issues, metallic taste in the mouth and cardiac abnormalities.

The FDA is currently gathering information about MoM hip systems, including information about adverse effects of increased levels of cobalt and chromium in the blood stream.

Current MoM hips with alleged injuries include the Zimmer Duron Cup, the DePuy ASR, the DePuy Pinnacle and the Wright Conserve.

If you or a loved one is currently suffering from a MoM hip replacement, contact Robert D Rowland.

The DePuy Artificial Hip and The Implant Loophole

Posted on December 27th, 2010

In a recent in-depth look at Johnson and Johnson’s DePuy A.S.R. artificial hip, the New York Times called it “one of the most troubled orthopedic implants of the past decade.”

Originally touted as a breakthrough implant, patients who received the DePuy artificial hip developed pain, swelling, and problems walking. Many required additional operations in which the device was replaced with yet another artificial hip. Some patients were left permanently disabled from damage to bone, muscles and nerves from the device, which shed tiny metallic particles. Yet as patients complained, doctors were largely unaware of how widespread the problem was since no independent monitoring system exists in the U.S. to track implant failures.

The failure of the DePuy hip has critics pointing out the larger failure in the medical implant system itself. Whereas new pharmaceutical drugs must go through a series of clinical trials before receiving approval from the Food and Drug Administration, implants do not need to follow the same rules. They can be sold without any testing at all if the device resembles an implant already approved and used on patients. Manufacturers can make small changes to a device and rapidly put it on the market without testing. As shown with the DePuy A.S.R., it’s a loophole that has already proven to have alarming consequences.

But changes may be on the way. The F.D.A has recently proposed rules that could require implanted devices to undergo more thorough testing before they were approved for sale. However, the fate of those proposals is unclear and the implant device industry is questioning the need for broad changes.

Are you or a loved one suffering from a DePuy Hip Replacement Product? Please contact us.

DePuy Hip Recall

Posted on September 15th, 2010 by Robert D. Rowland

The decision to undergo an expensive and very painful hip replacement surgery is not something taken lightly. The majority of patients in need of a new hip are at an advanced age and the risks and complications of surgery are considerable. One factor in determining the right time to undergo a joint replacement surgery is the “life expectancy” of the product. Most hip replacement systems are expected to last 15 years or more before any need for additional surgeries or replacements are necessary. Unfortunately for thousands of people who received the Johnson & Johnson/DePuy ASR or ASR XL Hip Replacement Systems, that time span has been much shorter. The DePuy devices have a metal-on-metal ball and socket design. The metal on metal design can cause metal debris early in the life of the implant resulting inflammation and damage to muscles and soft tissue. The end result is a very expensive and painful replacement surgery. Many have been required to undergo revision and/or replacement surgeries within 2 to 5 years of the original implant.

Second hip replacements are much more difficult, pose greater risks of complications and have a greater chance of failure. Hip revision surgery is more complicated and more risky than the initial hip replacement because the surgeon must ream out more bone from the pelvis and cut tissue from the first surgery. A second surgery also exposes the patient to the risk of infection present in any hip surgery. Having a second surgery earlier than expected also expedites the need for additional revisions.

If you are a recipient of a DePuy hip replacement and have experienced some of the symptoms below, you may be at risk.

• Unexplained Hip Pain
• Thigh Pain or Groin Pain
• Pain and/or popping with Walking
• Pain Rising from a Seated Position
• Pain with Weight Bearing

If you feel you may be a victim of a faulty DePuy device, please contact us at 1-888-752-4302 or info@goldenbergheller.com.

Recent DePuy Hip Recall Makes Need for National Medical Device Registry More Evident

Posted on September 14th, 2010 by Robert D. Rowland

Buried within the America’s Affordable Health Choices Act of 2009 (H.R. 3200), is the National Medical Device Registry requirement. Signed into law this year, the National Medical Device Registry will require manufacturers to record all implantable devices. The registry will list devices by type, model and serial number or other unique identifiers. It is intended to help Health and Human Services assess the post-market safety and effectiveness of all devices that are implantable, life-supporting or life-sustaining.

The recent recall of the DePuy Hip Replacement products, ASR and ASR XL, is the perfect example of why this new registry may prove to be extremely valuable to consumers. The DePuy hip products have been on the market in the United States since 2005. Beginning in 2008, the FDA reported over 300 complaints from doctors and patients that the products had an early failure rate. Keep in mind that many people do not complain directly to the FDA so this leads me to believe that the problem is quite larger. For example, the National Joint Registry of England and Wales showed that 1 out of every 8 DePuy patient may suffer premature hip replacement failure and require additional surgery. If the national registry were in effect in 2005, many Americans could possibly have avoided the unnecessary pain, risk and expense the defective products are causing. The registry would have triggered a red flag (and potentially a FDA recall) much earlier than DePuy’s August 2010 voluntary recall. If the registry were in effect, consumers in the U.S. would have known even earlier than Australian citizens about the risk of DePuy hip failure. Australia removed DePuy from the market in December of 2009.

If you are a recipient of a Johnson & Johnson DePuy ASR or ASR XL hip replacement system, and feel that you may be a victim of a faulty DePuy devise, please contact us at 1-888-752-4302 or info@goldenbergheller.com.